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A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Who is this study for? Patients with MET-altered advanced non-small cell lung cancer
What treatments are being studied? REGN5093
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol

• Willing to provide tumor tissue as described in the protocol

• Documented presence of MET alteration as described in the protocol.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ and bone marrow function as described in the protocol

Locations
United States
Alabama
University of Alabama at Birmingham
WITHDRAWN
Birmingham
California
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
COMPLETED
Orange
Washington, D.c.
Georgetown University Medical Center
COMPLETED
Washington D.c.
Florida
Moffitt Cancer Center - McKinley Drive
RECRUITING
Tampa
Kentucky
University of Kentucky, Markey Cancer Center Clinical Research Organization
WITHDRAWN
Lexington
Massachusetts
Dana Farber Harvard Cancer Center Consortium
COMPLETED
Boston
DNU_Massachusetts General Hospital_DNU
WITHDRAWN
Boston
Michigan
Henry Ford Health System
WITHDRAWN
Detroit
Missouri
Washington University School of Medicine
WITHDRAWN
St Louis
North Carolina
Duke Cancer Center
WITHDRAWN
Durham
New York
Icahn School of Medicine at Mount Sinai
COMPLETED
New York
Memorial Sloan Kettering Cancer Center
COMPLETED
New York
NYU Cancer Institute
WITHDRAWN
New York
Oklahoma
Stephenson Cancer Center
WITHDRAWN
Oklahoma City
Pennsylvania
Fox Chase Cancer Center
WITHDRAWN
Philadelphia
University of Pittsburgh UPMC - Clinical Research Services
COMPLETED
Pittsburgh
Texas
Harold C. Simmons Comprehensive Cancer Center
WITHDRAWN
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
France
Institut Bergonie
COMPLETED
Bordeaux
Centre Francois Baclesse (CFB)
COMPLETED
Caen
Centre Georges Francois Leclerc
WITHDRAWN
Dijon
Centre Hospitalier Universitaire de Grenoble
COMPLETED
Grenoble
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
COMPLETED
Montpellier
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
COMPLETED
Rennes
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Chungbuk National University Hospital
RECRUITING
Cheongju-si
National Cancer Center
RECRUITING
Gyeonggi-do
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Haeundae Paik Hospital
RECRUITING
Pusan
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Boramae Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seol St. Mary's Hospital
COMPLETED
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University Of Korea St. Vincent's Hospital
RECRUITING
Suwon
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2020-01-07
Estimated Completion Date: 2032-04-22
Participants
Target number of participants: 231
Treatments
Experimental: REGN5093
Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov